Trevena Reports First Quarter 2020 Results

FDA review of oliceridine NDA ongoing; PDUFA date August 7, 2020

CHESTERBROOK, PA — Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, reported its financial results for the first quarter ended March 31, 2020, and provided an overview of its recent operational highlights.

“In the first quarter, we reached a significant milestone for the oliceridine program, with our resubmission and FDA’s acceptance of the NDA. I am very pleased with FDA’s engagement in the review process, and we look forward to receiving their decision in August,” said Carrie Bourdow, President and Chief Executive Officer of Trevena, Inc.

First Quarter 2020 and Recent Corporate Highlights:

  • Resubmitted NDA for oliceridine, with FDA review ongoing. In March 2020, the Company announced that the U.S. Food and Drug Administration (FDA) had set a Prescription Drug User Fee Act (PDUFA) goal date of August 7, 2020 for oliceridine, and the Agency considered the resubmitted New Drug Application (NDA) to be a complete response to their 2018 action letter.FDA’s review of the NDA resubmission is ongoing, and the Company continues to expect a decision from the Agency by August 7.
  • Further expanded body of peer-reviewed literature. The Company recently announced the publication of a comprehensive review of the nonclinical and clinical data for oliceridine. The monograph provides an overview of the data the Company has published over the past 18 months, including head-to-head data versus IV morphine in hard- and soft-tissue surgical models and safety / tolerability data in high-risk patients from an open-label, “real world” safety study. These high-risk patients –  elderly, obese, renally impaired and / or co-morbid – make up the initial target market for oliceridine.
  • Initiated collaboration with NIH to evaluate TRV045 for epilepsy and non-addictive treatment for pain. In March 2020, the Company announced it had entered into a collaboration with NIH to evaluate the potential of TRV045, the lead candidate for its novel S1P receptor modulator program, as a treatment for epilepsy. NIH has initiated the first round of assays for TRV045 within its Epilepsy Treatment Screening Program.The Company today announced that NIH is also investigating TRV045 as a potential non-addictive treatment for various acute and chronic pain conditions, including inflammatory and neuropathic pain, within its Preclinical Screening Platform for Pain.
  • Advanced IND-enabling activities for TRV045. The Company today announced it plans to file an Investigational New Drug (IND) application for TRV045 in 1H 2021. IND-enabling activities are currently ongoing.
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Financial Results for First Quarter 2020

For the first quarter of 2020, the Company reported a net loss attributable to common stockholders of $5.7 million, or $0.06 per share, compared to $5.2 million, or $0.06 per share, for the first quarter of 2019. This increase in net loss is primarily due to higher research and development expenses associated with the TRV250 acute migraine proof-of-concept study and activities to support the NDA resubmission for oliceridine.

Cash and cash equivalents were $28.1 million at March 31, 2020, which the Company believes to be sufficient to fund the Company’s operating expenses and capital expenditure requirements into the first quarter of 2021.

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